Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
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| With that, as I bring my prepared remarks to a close, I'd like to say how incredibly proud I am of the team and the progress we've made in 2023 |
| As reported, we had a great launch year, and year two while early is taking shape, and we're excited about our target guidance for this year of $220 million to $260 million in U.S |
| We've got once a month from one of the subcu products, and the other is once every six months with a pretty clunky product, as far as we can tell and so somewhere in between we think we'd be very successful |
| And as I said, we're feeling really good about our guidance to the higher end of that range, and then any other details we'll discuss on the next quarter call |
| I mean, there's a lot of detail in those patents, but I think the sum in some sense is that in addition to a new composition of matter patent that covers the glycosylation profile of BRIUMVI plus some use patents within that, we feel good about the 2042 patent protection |
| We kicked off the year with the launch of BRIUMVI for relapsing forms of multiple sclerosis toward the end of January and saw a nice sales momentum carried throughout the year, resulting in approximately $90 million in U.S |
| We believe these first-year revenues speak to the high level of early interest and strong underlying demand for BRIUMVI, and we look forward to continued carry-through in 2024, where we are targeting $220 million to $260 million in U.S |
| The feedback from physicians, patients, nurses and infusion centers continues to be very positive, and drives our confidence in both the short-term revenue ramp, as well as the long-term blockbuster potential of BRIUMVI |
| I can't promise that that's what's going to happen, but we do think that there's an interesting opportunity |
| As you know, it's still early, but what I said in my remarks is true so far that the trends seem positive and around what we expected based on what we saw with the other IV CD20 |
| We also feel very good about our full year guidance of $220 million to $260 million, which we provided at JP Morgan |
| So far this year is off to a really strong start, where we have seen record enrollments into our Hub in January |
| Based on our market research and extensive interaction with neurologists, we continue to believe BRIUMVI's profile remains very compelling and will eventually be the IV therapy of choice in the relapsing MS market |
| We also believe we have significant room to grow in what is a large and growing and expanding market |
| We believe this is a continued tailwind for our business |
| The cumulative effects of what we've accomplished certainly helped to drive momentum that we saw in 2023, and we expect to see that momentum carry forward this year |
| We are very proud of our teams and believe their outstanding efforts are contributing to the positive experience with BRIUMVI and continue to build confidence in our organization |
| We built a best-in-class patient support team, and our highly experienced and well-networked field teams have done an incredible job establishing TG as a respected partner in the MS community |
| From an execution perspective, our team’s did an exceptional job delivering on our launch plan in 2023 |
| We were also highly encouraged by the persistence of returning patients, which so far appears to be consistent with our assumptions, which was based on what had been seen with the other IV anti-CD20 on the market |
| In fact, the fourth quarter was the first time we saw more scripts from academic centers than in a private practice setting, which we view as positive progress given that 60% to 65% of patients are being seen by MS specialists in the academic setting, and this has been a focus for our team as we headed into the end of the year |
| We saw an increasing number of repeat prescribers and incremental gains in new prescribers and new centers adopting BRIUMVI |
| The fourth quarter number exceeded our guidance and reflects the growing demand we are seeing for BRIUMVI |
| And more importantly, we made a positive difference in the lives of thousands of people living with MS |
| We've built a strong commercial infrastructure that delivered exceptional results, exceeded expectations on the launch, and now provides a solid platform for which to build potential blockbuster products in MS and capitalize on other autoimmune disease opportunities going forward |
| Overall, we believe azer-cel is a great fit for us and an important addition to our current pipeline |
| One obvious difference is that BRIUMVI is the only anti-CD20 monoclonal antibody that can be given as a one-hour infusion every six months after the starting dose, which may be an attractive profile for both patients who want to get back to their daily lives and for healthcare practices seeking to increase the efficiency within their infusion suites |
| That said, our drug development team is poised and ready to potentially drive additional value through BRIUMVI lifecycle management activities, as well as new drug development |
| We believe azer-cel has the potential to be a first-in-class, best-in-class treatment for certain autoimmune diseases |
| As you can see, we have put together a thoughtful and exciting development plan for 2024 and beyond that we believe can add significant value to our shareholders |
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| And if there's any signal that we'd somehow be losing some activity by eliminating the 150 milligrams |
| For the fourth quarter of 2023, we reported a net loss of $14.4 million or $0.09 per diluted share |
| We're not too worried about external parties |
| Some investors are still curious about the trends |
| Other outside parties I'm not too worried about |
| Having said that, this is a competitive market and BRIUMVI is the newest entry, so differentiation matters |
| There are a lot of things you can control in that process, and there's things that are outside your control |
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